A Randomized Trial to Assess the Role of Imaging During Follow Up After Radical Surgery of High Risk Melanoma
TRIM
A Prospective Randomized Multicenter Trial to Assess the Role of Imaging During Follow Up After Radical Surgery of Stage IIb-c and III Cutaneous Malignant Melanoma
1 other identifier
interventional
1,300
1 country
20
Brief Summary
It is not known whether radiological assessments during follow up after surgery for high risk melanoma improve survival. Since radiological examinations are resource demanding, could inflict worry and cause irradiation exposure it is an important question to address. With the introduction of effective medical treatments for malignant melanoma patients, there is a tendency to introduce radiological assessments despite the lack of evidence.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2017
Longer than P75 for not_applicable
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 14, 2017
CompletedFirst Posted
Study publicly available on registry
April 17, 2017
CompletedStudy Start
First participant enrolled
June 8, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
December 16, 2024
December 1, 2024
11.6 years
March 14, 2017
December 11, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival
Measured from date of inclusion
At 5 years
Secondary Outcomes (2)
Quality of life/QLQ30
During the 3 year intervention period
Quality of life/HAD
During the 3 year intervention period
Other Outcomes (1)
Disease free survival (DFS)
3 years
Study Arms (2)
Routine follow up
NO INTERVENTIONFollow up according to national guidelines.
Radiological assessments
EXPERIMENTALRadiological assessments (CT or PET scans) at 5 occasions during 3 years.
Interventions
Scans and blood tests are scheduled at baseline, months 6, 12, 24 and 36.
Eligibility Criteria
You may qualify if:
- At least 18 years of age.
- Radical surgery for Cutaneous Malignant Melanoma (CMM) stage IIb-c and III.
- Sufficient renal function for i.v. contrast scannings.
You may not qualify if:
- The patient is assessed as unfit to receive treatment in the case of recurrence.
- Life-expectancy less than 2 years due to concurrent disease (e.g., cardiac disease, terminal multiple sclerosis, liver cirrhosis).
- Inability to provide informed consent or refusal to do so.
- Inability to comply with the control or intense follow-up program.
- Participation in other clinical trials interfering with the control-program.
- Existing or previous malignancies within the past 5 years (except for in situ breast and cervical cancer, melanoma in situ and non-melanoma skin cancer).
- Pregnancy or currently planned pregnancy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Södra Älvsborgs sjukhus
Borås, Sweden
Mälarsjukhuset Eskilstuna
Eskilstuna, Sweden
Falu lasarett
Falun, Sweden
Gävle sjukhus
Gävle, Sweden
Department of Surgery, Sahlgrenska University Hospital
Gothenburg, Sweden
Helsingborgs lasarett
Helsingborg, Sweden
Länssjukhuset Ryhov
Jönköping, Sweden
Länssjukhuset i Kalmar
Kalmar, Sweden
Centralsjukhuset i Karlstad
Karlstad, Sweden
Linköping University Hospital
Linköping, Sweden
Skåne University Hospital
Malmo, Sweden
Örebro University Hospital
Örebro, Sweden
Skaraborgs sjukhus Skövde
Skövde, Sweden
Karolinska University Hospital
Stockholm, Sweden
Länssjukhuset Sundsvall
Sundsvall, Sweden
Uddevalla sjukhus
Uddevalla, Sweden
Umeå University Hospital
Umeå, Sweden
Akademiska sjukhuset
Uppsala, Sweden
Västmanlands sjukhus Västerås
Västerås, Sweden
Visby lasarett
Visby, Sweden
Related Publications (2)
Ladjevardi CO, Naeser Y, Dyrke U, Papantoniou D, Bagge RO, Elander N, Ingvar C, Flygare P, Nilsson C, Jakobsson F, Lange-Norstrom K, Sundin A, Berglund A, Nyberg F, Ahringberg-Kald B, Helgadottir H, Ullenhag G. Physical examinations and whole-body imaging versus physical examinations alone during follow-up after radical surgery of stage IIB-C and III cutaneous malignant melanoma (TRIM): an interim analysis of a multicentre, randomised, phase 3 trial in Sweden. Lancet Oncol. 2025 Nov;26(11):1501-1510. doi: 10.1016/S1470-2045(25)00487-5.
PMID: 41167217DERIVEDNaeser Y, Helgadottir H, Brandberg Y, Hansson J, Bagge RO, Elander NO, Ingvar C, Isaksson K, Flygare P, Nilsson C, Jakobsson F, Del Val Munoz O, Valachis A, Jansson M, Sparring C, Ohlsson L, Dyrke U, Papantoniou D, Sundin A, Ullenhag GJ. TRIM study protocol - a prospective randomized multicenter Trial to assess the Role of Imaging during follow-up after radical surgery of stage IIB-C and III cutaneous malignant Melanoma. BMC Cancer. 2020 Dec 7;20(1):1197. doi: 10.1186/s12885-020-07632-4.
PMID: 33287744DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gustav Ullenhag, associate professor
Uppsala University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2017
First Posted
April 17, 2017
Study Start
June 8, 2017
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
December 16, 2024
Record last verified: 2024-12